BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982630 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00301
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOM REPORTED THAT THE PUMP'S BATTERY WAS HOT. THE PT'S MOM STATED THERE WAS WHITE RESIDUE ON THE BATTERY AND INSIDE THE BATTERY COMPARTMENT. THE PUMP HAS BEEN EXPOSED TO WATER IN THE SHOWER. THE PUMP WAS REPLACED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1